Study Finds that Elderly are Severely Underrepresented in Clinical Trials

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Half of all new cancer cases occur inpeople older than 65, yet a growing body of evidence shows that elderly patients are chronically underrepresented in clinical trials. Moreover, it has been presumed that older patients cannot handle the aggressive chemotherapy used on younger patients, given that concurrent illnesses are common. But because there has been so little data on the effects of standard treatment regimens on older patients, physicians are often forced to make decisions about patient care inthe absence of clear scientific evidence.

The Southwest Oncology Group (SWOG), one of the largest NCI-sponsored cooperative clinical trials groups in the US, found that the proportion of patient over 65 enrolled in SWOG trials was less than half the expected rate. (Researchers analyzed the NCI's national registry of cancer patients, called SEER, and compared number of elderly patients in that registry to the numbers of elderly patients enrolled in their clinical trials.)

In SWOG, the elderly represented only 25% of trial participants, though 63% of patients in the SEER registry were over the age of 65. The study also examined trial enrollment by gender and race, and found that women were underrepresented for only a few types of cancer, and that the overall rate was 41% in SWOG compared to 43% from SEER. African-Americans were enrolled in SWOG clinical trials at rates comparable to those found in SEER (10% each).

This study provides evidence that the elderly are a special patient population which should be considered when designing clinical trials, and that studies to determine the barriers to elderly participation are needed. These findings are also espeically relevant as Americans live longer lives," concluded Dr. Haluska, MD, PhD, of Massachusetts General Hospital.